In a significant move aimed at preserving competition in the pharmaceutical industry, the Federal Trade Commission (FTC) has intervened to thwart a licensing deal between Sanofi and Maze Therapeutics. The deal, centered around the Pompe disease program MZE001, has been abandoned by Sanofi, marking a retreat rather than engaging in a protracted legal battle with the FTC.
The agreement, initially disclosed in May, entailed Sanofi paying $130 million upfront, with potential additional payments of up to $605 million in milestones. The focus of the collaboration was on a drug candidate designed to address Pompe disease by preventing the accumulation of glycogen. This candidate would have joined Sanofi’s existing Pompe portfolio, which includes the enzyme replacement therapy Nexviazyme.
The FTC’s objection to the deal revolves around concerns about potential anti-competitive effects. In an official statement outlining its decision to block the agreement, the agency expressed apprehension that the deal would “eliminate a nascent competitor poised to challenge Sanofi’s monopoly in the Pompe disease therapy market.” The FTC further elaborated on this point in a heavily redacted complaint, emphasizing the need to maintain a competitive landscape in the market.
Sanofi, in response to the FTC’s action, expressed respectful disagreement with the regulatory decision. The pharmaceutical giant argued that the collaboration with Maze Therapeutics would have allowed Sanofi to leverage its “resources, knowledge, and expertise to accelerate the development of MZE001.” Sanofi emphasized that the FTC’s intervention would result in delays, hindering potential advancements that could positively impact the lives of patients.
Despite its disagreement with the FTC, Sanofi has opted against contesting the regulatory move. The company announced the termination of the agreement, citing the extended timeframe associated with litigation. Sanofi stated that it concluded that challenging the FTC in court would not be in the best interests of patients, as the delay would impede potential advancements in the development of MZE001.
Source: Fierce Biotech